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Prospective Observational Study on Vertebral Metastasis

NCT05985434 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 191

Last updated 2024-01-03

No results posted yet for this study

Summary

Perspective observational cohort study in which the data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and surgical treatment candidates will be collected, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Rizzoli Orthopedic Institute starting from the date of approval of the same study.

Patients of both sexes and aged 18 years or older will be included. Patients with primary (benign or malignant) tumors of the vertebrae and patients unable to consent to the study will be excluded from the study.

For each patient, in addition to the demographic data, preoperative information will be collected: type of tumor, involved vertebral levels, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, neurological picture according to Frankel's scale, evaluated pain according to the Visual Analogue Scale (VAS), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on the quality of life; information related to the intervention itself: access, type of surgical treatment, possible preoperative embolization; intraoperative complications; information at discharge: postoperative complications, pain, neurological picture, functional status; follow-up data: pain, neurological picture, functional status, SF-36 questionnaire, late complications, local recurrence; systemic progression of the disease.

Follow-up checks will be performed at 3 months, 6 months, 12 months, 18 months, 24 and 36 months. The timing of the controls and the examinations requested by the patients will be those of normal clinical practice.

Primary endpoint is the change in quality of life (measured by scores EQ-5D and SF-36) and pain (measured using the VAS score) following surgery compared to pre-operative values.

Conditions

  • Vertebral Metastasis

Interventions

PROCEDURE

Surgical treatment

decompression with or without stabilization; stabilization only; debulking; en bloc resection

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Silvia Terzi, MD · Istituto Ortopedico Rizzoli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-21
Primary Completion
2022-12-01
Completion
2023-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985434 on ClinicalTrials.gov